Projects that qualify for exempt status review under UAMS IRB policy 7.3 are not subject to many of the usual requirements in the Common Rule (current or, after Jan. 21, revised). However, the IRB still reviews all exempt status studies for compliance with the ethical principles underlying human subject research (beneficence, justice, autonomy) and, starting in a few weeks, for certain revised Common Rule requirements, such as ensuring data confidentiality measures are appropriate.
As the Revised Common Rule (RCR) will expand the types of studies that qualify for exempt status, we expect an increase in the number of studies subject to exempt status review. When preparing a submission that you think will qualify for exempt review status, please keep in mind that some sort of informed consent process will typically still be required for projects that involve direct subject interaction. While you may not need to obtain signed consent forms from these subjects, you will likely still have to describe a consent process in your submission, and may be asked to create written information to give to subjects as part of the consent process. So be prepared to address those issues in your submission.
Also, please remember that qualifying for exempt status review doesn’t automatically exempt you from HIPAA. If your project involves protected health information, appropriate HIPAA requirements must still be met.